T-Cell Therapy (ECT204) in Adults With Advanced HCC

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, dose escalation, multi-center, Phase I/II clinical trial aimed at assessing the safety and preliminary efficacy of an investigational ARTEMIS® ECT204 T-cell therapy. The trial is suitable for adult subjects (≥ 18 years of age) diagnosed with GPC3-positive HCC, who have failed or not tolerated at least two (2) different anti-HCC systemic agents.

Phase I has concluded and a Recommended Phase II Dose (RP2D) has been determined. We are now conducting Phase II to further confirm the safety profile of ECT204 and evaluate its efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eureka Therapeutics Inc.

Criteria

Inclusion Criteria:

• Histologically confirmed HCC, which is unresectable, recurrent and/or metastatic.

• GPC3-positive expression in HCC tumor cells confirmed by immunohistochemistry (IHC). To be eligible for Phase 2 (expansion phase) of the study, the subject's tumor biopsy sample (resection or needle core sample) must demonstrate that more than 50% of tumor cells exhibit at least 3+ GPC3 expression intensity.

• Must have failed, or not tolerated, at least two (2) different anti-HCC systemic agents.

• Life expectancy of at least 4 months per the Investigator's opinion.

• Karnofsky Performance Scale of 70 or higher.

• Measurable disease by RECIST v1.1. Previously treated lesions are allowed as long as there is a new confirmed measurable component.

• Child-Pugh score of A6 or better.

• Adequate organ function.

Exclusion Criteria:

• Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.

• Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.

• Active malignancy (other than HCC), with the exception of cholangiocarcinoma (CCA) or any malignancy without any organ involvement and with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen- deprivation therapy).

• Currently receiving or ending (< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.

• Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.

• Active autoimmune disease requiring therapy.

• Compromised circulation in the main portal vein, hepatic vein, or vena cava due to obstruction.

• History of organ transplant.

• Advanced HCC involving greater than half (50%) of the liver.